Marketing

ASTM F2459 PDF

New ASTM F Standard Test Method for Extracting Residue from Metallic Medical Components and Quantifying via Gravimetric Analysis. ASTM F – Standard Test Method for Extracting Residue from. Metallic Medical Components and Quantifying via Gravimetric. Analysis. • ASTM F a baseline and set acceptance parameters for cleanliness. ASTM F Chemical Residue by. Gravimetric Analysis. This document provides a quantitative.

Author: Taujora Vudosho
Country: Syria
Language: English (Spanish)
Genre: Photos
Published (Last): 16 June 2017
Pages: 268
PDF File Size: 10.5 Mb
ePub File Size: 16.97 Mb
ISBN: 846-9-17768-983-8
Downloads: 25287
Price: Free* [*Free Regsitration Required]
Uploader: Brall

Please login to your authorized staff account to use this feature. Remember me for one month. Link to Active This link will always route to the current Active version of the standard.

Are you sure you want to empty the cart? This test method is also not intended to extract residue for use in biocompatibility testing. This standard does not purport to address all of the safety concerns, if any, associated with its use. This test method is suitable for determination of the extractable residue in metallic medical components. This test method recommends the use of a sonication ashm to extract residue from the medical component. Copyright Compu-tecture, Inc.

Note 1For extraction of samples intended for the biological evaluation of devices or materials, refer to ISO Historical Version s – view previous versions of standard. Work Item s – proposed revisions of this standard. No other units of measurement are included in this standard. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use. Print 1 2 3 4 5 page sstarting from page current page.

It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use. Search book title Enter keywords for book title search. Register for a trial account.

  BIOCALCULUS STEWART PDF

New ASTM F Standard Test Method for Extracting Residue

No other units of measurement are included in this standard. This test method is not applicable for evaluating the f249 residue for the reuse of a single-use component SUD.

Historical Version s – view previous versions of standard. This practice proposes how to f22459 the identification of critical compounds and suggests different analytical methods.

This test method is also not intended to extract residue for use in biocompatibility testing. If you like to setup a quick demo, let us know at support madcad.

Referenced Documents purchase separately The documents listed below are referenced within the subject standard but are not provided as part of the standard. In addition, it is recognized that this test method may not be the only method to determine and quantify extractables.

FORMAT Single User Subscription Site License Subscription BOOKS All Asstm PACKAGES All Packages EDITION to PUBLISHER.

Extractable residue includes aqueous and non-aqueous residue, as well as non-soluble residue. Referenced Documents purchase separately The documents listed below are referenced within the subject standard but are not provided as part of the standard.

Link to Active This link will always route to the current Active version of the standard. Residues may also cause harm at locations away from the implant.

It identifies one technique to quantify extractable residue on metallic medical components. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use. Click here to download full list of books. Residues may originate from manufacturing materials used in the course of processing or from the manufacturing environment, or may be the result of handling and packaging 1- 3.

  KAKO PREBACITI TEKST IZ WORDA U PDF

Work Item s – proposed revisions of this standard. In particular, it does not address substances released during implant resorption, implant coatings, or leachables by design. Other techniques, such as solvent reflux extraction, could be used but have been shown to be less efficient in some tests, as discussed in X1.

ASTM-F, –

It suggests standard techniques that may be applied for analysis, and provides suggestions for how limit values may be set. They may exhibit as surface-bound substance, or as adsorbates for example, electrostatically heldefflorescence, or mechanically held substances. Extractable residue includes aqueous and non-aqueous residue, as well as non-soluble residue.

This test method is also not intended to extract residue for use in biocompatibility testing. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

Referenced Documents purchase separately The documents listed below are referenced within the subject standard but are not provided as part of the standard. Active view current version of standard.

ASTM F2459 – 18

Other techniques, such as solvent reflux extraction, could be used but have been shown to be less efficient in some tests, as discussed in X1. It identifies two techniques to quantify extractable residue on metallic medical components. In addition, it is recognized that this asmt method may not be the only method to determine and quantify extractables. Residues may be soluble in aqueous media, soluble in organic solvents, or may be insoluble particulates.

For extraction of samples intended for asmt biological evaluation of devices or materials, refer to ISO —